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510(k) K780135

CEMENT EXTRACTION INSTRUMENT SET by Orthopedic Equipment Co., Inc. — Product Code KDG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 1978
Date Received
January 24, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chisel (Osteotome)
Device Class
Class I
Regulation Number
878.4820
Review Panel
SU
Submission Type

Other clearances by Orthopedic Equipment Co., Inc.

  • K834035 — UNIVERSAL SELF-ALIGNING ACETABULAR COM (June 19, 1984)
  • K841189 — OEC/REZAIAN SPINAL FIXATOR (May 16, 1984)
  • K800530 — SCHLEIN TRI-SURFACE ANKLE (April 2, 1980)
  • K781445 — SPREADER (September 27, 1979)
  • K790209 — FILTER SYSTEM, ALTNER DISPOSABLE (February 26, 1979)
  • K790247 — TOURNIQUET TEST GAGE (February 26, 1979)
  • K781447 — THREADED ROD CLAMP (September 27, 1978)
  • K781448 — HARRINGTON HOOK CLAMP (September 27, 1978)
  • K781444 — OUTRIGGER DISTRACTION UNIT (September 27, 1978)
  • K781443 — HARRINGTON SPINE INSTRUMENTATION (September 27, 1978)

Other clearances for product code KDG

  • K952678 — STA-CLEAR ALCOHOL-FREE ENDOSCOPIC ANTI-FOG KIT (July 10, 1995)
  • K952200 — OMNI-JUG (June 29, 1995)
  • K894785 — SURGICAL CHISEL/OSTEOTOME (August 18, 1989)
  • K891471 — SIL-MED WASTE FLUID DUMP BAG (August 15, 1989)
  • K872947 — POREX QUALITY PLASTIC SURGERY INSTRUMENTS (August 21, 1987)
  • K872092 — OSTEOTOME SET, HOKE, STRAIGHT, SET OF 5 (June 23, 1987)
  • K842824 — CHERMEL BONE CHISELS (August 2, 1984)
  • K772373 — ANDERSON-NEIVERT OSTEOTOME (March 9, 1978)
  • K772376 — NEIVERT OSTEOTOME (March 9, 1978)
  • K772374 — SILVER OSTEOTOME (March 9, 1978)